Standard Treatment Response for Rectal Cancer

Recruiting at 5 trial locations

Overseen By Andrea Cercek, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Fluoropyrimidines

Must not be taking: Blood thinners

Disqualifiers: Prior malignancy, Prior pelvic radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the body responds to standard treatments for rectal cancer, such as chemoradiation (a combination of chemotherapy and radiation therapy) and chemotherapy. Researchers will examine blood, tissue, and scan results to determine if these treatments improve, worsen, or maintain the condition. The trial includes an endoscopy (a procedure to look inside the body) to gather additional information. Suitable participants have been diagnosed with rectal cancer and are beginning standard treatment. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance future treatment strategies for rectal cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on blood thinners, you may not be eligible to participate.

Is endoscopy generally safe for humans?

Endoscopy is generally safe, but it can have some risks. Serious side effects, like bleeding and tears in the colon, happen in about 2.8 out of every 1000 procedures, especially when removing growths (polypectomy). ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of endoscopy in treating rectal cancer because it offers a minimally invasive approach to assess and potentially remove cancerous tissue. Unlike traditional surgery, which can be more invasive and require longer recovery times, endoscopy allows doctors to directly visualize and treat the affected area with precision. This method may lead to quicker recovery, less discomfort, and a more accurate evaluation of how well the cancer is responding to neoadjuvant therapy, which is the treatment given before the main treatment.

What data supports the effectiveness of the treatment Endoscopy, Endoscopic examination, Gastrointestinal endoscopy for rectal cancer?

Research shows that endoscopic examination is important in identifying a complete response in rectal cancer patients after chemoradiotherapy, which can help determine if a nonoperative approach is suitable. ^{6 7 8 9 10}

Who Is on the Research Team?

Paul B. Romesser

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with rectal cancer, specifically adenocarcinoma. Participants will undergo standard treatments before potential surgery. The study aims to include those who can provide blood and tissue samples, as well as undergo scans.

Inclusion Criteria

My rectal cancer is confirmed and does not have specific genetic features.

I am starting standard chemotherapy for my condition.

I am a woman who can become pregnant, not currently pregnant, and agree to use birth control during the study.

Exclusion Criteria

I am on blood thinners that prevent me from having certain cancer tissue tests.

I am not using any form of birth control.

I have had radiation therapy to my pelvis or seed implantation in my prostate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoradiation

Participants receive standard chemoradiation therapy as part of neoadjuvant treatment

5-6 weeks

Chemotherapy

Participants receive standard chemotherapy following chemoradiation

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopy

Trial Overview The trial is studying how people with rectal cancer respond to the usual treatment combo of chemoradiation and chemotherapy. It involves monitoring changes in the body through blood tests, tissue analysis, and imaging scans.

How Is the Trial Designed?

Group I: Participants with Rectal Cancer Experimental Treatment 1 Intervention

Participants will be diagnosed with rectal cancer and will be undergoing standard-of-care neoadjuvant therapy.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Endoscopy can effectively identify over 70% of patients with a clinical complete response (CR) after neoadjuvant treatment for rectal cancer, with a median time to endoscopy of about 9 weeks.

The presence of a flat scar during endoscopy is the most predictive feature of CR, with a positive predictive value of 70%-80%, suggesting that specific endoscopic findings can help determine which patients may benefit from a watch-and-wait approach for organ preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive Value of Endoscopic Features for a Complete Response After Chemoradiotherapy for Rectal Cancer. van der Sande, ME., Maas, M., Melenhorst, J., et al.[2021]

A study of over 2.3 million outpatient colonoscopies revealed that more complex polypectomy techniques, such as snares and hot forceps, significantly increase the risk of serious gastrointestinal adverse events like colonic perforations and GI bleeding compared to simple colonoscopy.

Patients treated by low-volume endoscopists and those undergoing procedures in ambulatory surgery centers also faced higher risks of complications, suggesting that opting for simpler techniques or high-volume specialists could help reduce these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of polypectomy techniques, endoscopist volume, and facility type with colonoscopy complications. Chukmaitov, A., Bradley, CJ., Dahman, B., et al.[2023]

A new grading system for the complexity of endoscopic procedures was established through consensus voting among gastroenterologists in the US, Canada, and Britain, categorizing procedures from level 1 (easiest) to level 4 (most difficult).

This consensus list aims to enhance the understanding of procedure complexity, complementing existing lexicons for adverse events and risk factors, although it is based more on expert opinion than empirical evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Grading the complexity of endoscopic procedures: results of an ASGE working party. Cotton, PB., Eisen, G., Romagnuolo, J., et al.[2022]

In a study of 226 patients who underwent endoscopic resection for superficial duodenal epithelial tumors, the surgical conversion rate due to adverse events was 8.0%, with delayed perforation presenting the highest risk for conversion at 50%.

Significant risk factors for surgical conversion included involvement of the major papilla and delayed perforation, highlighting the need for careful monitoring and prevention strategies within the first three days post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical course and management of adverse events after endoscopic resection of superficial duodenal epithelial tumors: Multicenter retrospective study. Dohi, O., Kato, M., Takeuchi, Y., et al.[2023]

The AGREE classification system for adverse events in gastrointestinal (GI) endoscopy was validated and showed an 80% agreement in severity perception among endoscopists, nurses, and patients, indicating its reliability.

The AGREE classification correlated significantly with the established ASGE classification, and was deemed simple, reproducible, and useful by 96% of experts, suggesting it can enhance the standardization and quality assurance of AE reporting in GI endoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel classification for adverse events in GI endoscopy: the AGREE classification. Nass, KJ., Zwager, LW., van der Vlugt, M., et al.[2023]

Endoscopic evaluation of complete response (E-CR) after preoperative chemoradiotherapy in rectal cancer showed a high accuracy of 91.7%, indicating it is a reliable method for assessing tumor response.

The study found that E-CR criteria led to all cases of clinical complete response (ycCR) being confirmed as pathological complete response, suggesting that this evaluation method can effectively guide treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic evaluation of clinical response after preoperative chemoradiotherapy for lower rectal cancer: the significance of endoscopic complete response. Ogura, A., Chino, A., Konishi, T., et al.[2018]

Surgeons showed significant variation in assessing tumor response in rectal cancer patients after neoadjuvant treatment, but they were generally consistent in identifying complete responses, achieving an accuracy of 82%.

The study highlights the importance of endoscopic examination in determining treatment response, suggesting that while there is variability among surgeons, the interpretation of endoscopic features for grading tumor response is reliable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Feature and Response Reproducibility in Tumor Assessment after Neoadjuvant Therapy for Rectal Adenocarcinoma. Felder, SI., Patil, S., Kennedy, E., et al.[2022]

Recent studies indicate that some rectal cancer patients who show a complete clinical response after neoadjuvant therapy may be effectively managed without surgery, suggesting a shift in treatment strategies.

This review highlights the importance of follow-up endoscopy in assessing patient responses to chemoradiotherapy, which can guide decisions on nonoperative management for those with significant improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of complete response after chemoradiation in rectal cancer. Weiser, MR., Beets-Tan, R., Beets, G.[2013]

In a study of 61 patients with high-risk rectal cancer, adding narrow-band imaging to conventional chromoendoscopy improved the inter-rater agreement between expert and trainee endoscopists, indicating better consistency in diagnosing clinical complete response after neoadjuvant therapy.

While the overall diagnostic accuracy for predicting pathologic complete response showed only a modest improvement (from 70.5% to 75.4%), narrow-band imaging did enhance sensitivity and negative predictive value, suggesting it may be a useful tool for standardizing assessments in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding Narrow-Band Imaging to Chromoendoscopy for the Evaluation of Tumor Response to Neoadjuvant Therapy in Rectal Cancer. Ishioka, M., Chino, A., Ide, D., et al.[2021]

A multimodal approach combining endoscopy and diffusion-weighted MRI (DWI-MRI) provides the most accurate assessment of response in early-stage rectal cancer after neoadjuvant chemoradiotherapy, achieving a high negative predictive value of 90.9%.

In a study involving 36 patients assessed by endoscopy and 25 patients assessed by DWI-MRI, the combination of both methods improved diagnostic accuracy significantly compared to using either method alone, indicating the importance of integrating different diagnostic tools for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopy and MRI for restaging early rectal cancer after neoadjuvant treatment. Stijns, RCH., Leijtens, J., de Graaf, E., et al.[2023]

Colonoscopy is generally safe, with an adverse event rate of 2.8 per 1000 procedures, but serious complications like hemorrhage and perforation are more common when polypectomy is performed.

The article emphasizes the importance of preventing and managing adverse events specifically related to polypectomy and endoscopic mucosal resection of colonic lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events related to colonic endoscopic mucosal resection and polypectomy. Sethi, A., Song, LM.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Predictive Value of Endoscopic Features for a Complete Response After Chemoradiotherapy for Rectal Cancer. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic evaluation of clinical response after preoperative chemoradiotherapy for lower rectal cancer: the significance of endoscopic complete response. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Adding Narrow-Band Imaging to Chromoendoscopy for the Evaluation of Tumor Response to Neoadjuvant Therapy in Rectal Cancer. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Endoscopic Feature and Response Reproducibility in Tumor Assessment after Neoadjuvant Therapy for Rectal Adenocarcinoma. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Management of complete response after chemoradiation in rectal cancer. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Association of polypectomy techniques, endoscopist volume, and facility type with colonoscopy complications. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Grading the complexity of endoscopic procedures: results of an ASGE working party. [2022]

8. Australia pubmed.ncbi.nlm.nih.gov

Clinical course and management of adverse events after endoscopic resection of superficial duodenal epithelial tumors: Multicenter retrospective study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse events related to colonic endoscopic mucosal resection and polypectomy. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Novel classification for adverse events in GI endoscopy: the AGREE classification. [2023]